This past year close to 100 new drugs were FDA-approved, so it’s encouraging to look back and see the progress that’s been made as 2015 ends. In fact, more than 40 novel drugs, including a new drug class for patients with high cholesterol, a first-time biosimilar, a life-saving heart failure drug, and a controversial agent to boost women’s libido, all successfully passed through the Agency’s halls.
With so many new approvals, it’s next to impossible to pick out those that are truly “tops.” What may be a top drug for one person — for example, an agent to extend survival from metastatic melanoma (Imlygic) — may not be a top drug to another patient who suffers with plaque psoriasis (Cosentyx). How can a new treatment that more easily reverses an opioid overdose (Narcan Nasal Spray) be “better” than an approval for advanced breast cancer (Ibrance). The bottom line is – they aren’t. But with so many varied and cutting-edge approvals this year, we had to pick a few.
One fact is consistent: the FDA has been increasing its NDA approval rate and regulatory efficiency year-after-year, with approvals ranging from orphan drugs to mega-blockbusters growing in numbers annually. Below are just a few of the “top” – and sometimes controversial – new drug approvals from 2015. If you need to access all of the FDA drug approvals and new indications from 2015, you can easily access them from Drugs.com.
Praluent and Repatha: First Approvals in New PCSK9 Inhibitor Class
- Blockbuster cholesterol drug class approved in 2015. Read more…
Sanofi and Regeneron’s Praluent (alirocumab) and Amgen’s Repatha (evolocumab) were approved in the summer of 2015. These are the first approvals in a potential blockbuster class of potent cholesterol-reducing agents known as PCSK9 inhibitors. In studies, levels of LDL cholesterol have dropped 40 to 60 percent. Praluent use is approved in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with heart attack or stroke who require further LDL lowering. Repatha injection is also indicated for heterozygous familial hypercholesterolemia (HeFH) and clinically significant heart disease, as well as homozygous familial hypercholesterolemia (HoFH). Side effects have included nasopharyngitis, injection site reactions, and respiratory tract infections.
FDA Approves First Biosimilar Product Zarxio
- In 2015, progress was made in the approval of U.S. biosimilars Read More…
March was a history-making month when FDA approved Sandoz’s Zarxio (filgrastim-sndz), the first U.S. approved biosimilar. Zarxio, the biosimilar for Amgen’s filgrastim (Neupogen), is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments. Biological products are generally derived from a living organism, including humans, animals, microorganisms or yeast. According to the RAND Corporation, biosimilars could save the U.S. health system close to $44 billion in the next ten years. Other top biologics facing future patent expiration include Humira (2018), Enbrel (2015), and Avastin (2019), all well-known blockbuster brands in the U.S.
Sprout’s Addyi For Low Libido in Women Clears FDA
- Controversy swirled around marketing “awareness” tactics for Addyi in 2015 Read More…
The controversial Addyi (flibanserin) by Sprout Pharmaceuticals was FDA-approved in August for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi, a multifunctional serotonin agonist antagonist (MSAA), is the first approved medication for HSDD. While Addyi showed modest benefit in clinical trials, it’s side effects, including fainting with alcohol use, prompted many labeling restrictions: a Boxed Warning, a REMS plan, required certification for providers and pharmacies, and a Patient-Provider Agreement Form. Addyi is given nightly as a 100 milligram bedtime dose, but should not be used in liver disease, with alcohol, and with many prescription drugs.
Praxbind Approved as Bleeding Reversal Agent for Pradaxa
- Praxbind approval in 2015 addressed a serious drawback to one of the newer anticoagulants Read More…
One of the major concerns with the newer oral anticoagulant Pradaxa (dabigatran) was that there was no reversal agent for bleeding. This problem was addressed in October with the approval of Praxbind (idarucizumab). Praxbind is an intravenous injection that binds to Pradaxa to neutralize its effect and control bleeding. In a study of 123 patients taking Pradaxa who received Praxbind due to uncontrolled bleeding or the need for emergency surgery, the anticoagulant effect of Pradaxa was fully reversed in 89 percent of patients within four hours. Common side effects include headache, low potassium (hypokalemia), confusion, constipation, fever and pneumonia.
FDA Approves Entresto for Heart Failure Six Weeks Early
- In 2015 analysts said Entresto could peak at $6 to $8 billion per year Read More…
In July, the U.S. Food and Drug Administration (FDA) approved Novartis’ Entresto, a twice-daily oral Angiotensin Receptor Neprilysin Inhibitor (ARNI) indicated to reduce the risk of death and hospitalization in patients with chronic heart failure. Entresto contains a combination of sacubitril, a first-in-class neprilysin inhibitor, and valsartan, an angiotensin II antagonist already FDA approved as Diovan. In the PARADIGM-HF Phase III study, Entresto was superior to ACE inhibitor enalapril. Entresto reduced the risk of death from cardiovascular causes and heart failure hospitalization by 20% and 21%, respectively, and reduced the risk of all-cause mortality by 16%.